BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5688428 · Received May 31, 2016

    Report

    Report Number
    6000034-2016-01109
    Event Type
    Injury
    Date Received
    May 31, 2016
    Report Date
    December 22, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED) DUE TO INFECTION AS PREVIOUSLY REPORTED. THIS REPORT IS SUBMITTED ON JANUARY 12, 2022.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE INTERNAL MAGNET WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2016, AND AN ABUTMENT WAS PLACED ONTO THE FIXTURE. THE IMPLANTED DEVICE REMAINS. THIS REPORT IS SUBMITTED ON (B)(6) 2016, BY (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THE IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT 510(K) NUMBER IS K100360, NOT K955713 AS REPORTED INITIALLY. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION ISSUES AT THE ABUTMENT SITE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344315 FLANGE FIXTURE AND ABUTMENT COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention